Light Protection and Blinding: A Two-Fold Benefit for Clinical Trials
SCHREINER MEDIPHARM
Light Protection and Blinding: A Two-Fold Benefit for Clinical Trials
In a current clinical trial for a novel antibody drug conjugate (ADC), a specialty Light-Protect-Label from Schreiner MediPharm is used. It reliably protects not only the light-sensitive active ingredient but also enables an inspection of the vial content in the original color. In addition, it neutralizes the investigational drugs within the clinical trial.
Antibody drug conjugates are an important innovation in cancer therapy. Through targeted delivery of drugs into specific tumor cells they enable gentler and more effective treatment compared to conventional chemotherapies. This technology acts directly on the cancer cell, thus largely sparing healthy cells and minimizing side effects.
WuXi XDC is a leading contract research, development, and manufacturing organization (CRDMO) headquartered in China with a focus on the global ADC and bioconjugate market. To support a biotech company in a clinical trial for an ADC drug, WuXi XDC required a reliable label solution. Because the light-sensitive active ingredient is filled into vials as a lyophilized powder, effective protection against external influences was necessary. WuXi XDC found the most suitable solution through the cooperation with Schreiner MediPharm by implementing a Light-Protect-Label that perfectly met the specific customer requirements.
Schreiner MediPharm developed a solution with integrated UV and light protection that is suitable for transparent vials. The opaque label completely wraps around the container and offers optimal protection while a resealable inspection window enables an unadulterated view of the content. That is crucial for inspecting the condition and color of the reconstituted lyophilisate before it is administered and to thus ensure the efficacy of the medication. At the same time, the label from Schreiner MediPharm supports a dependable and safe conduct of the clinical trial by reliably blinding the investigational drugs. Hence WuXi XDC benefits from an efficient, multi-functional solution combining the protection of the light-sensitive active ingredient with reliable blinding during the clinical trial. This optimizes processes, accelerates trial workflow, and supports product and patient safety.